An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study

NCT01727986 | Completed Phase 3

• 1 other identifier: ML28413
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

Brief Summary

This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

• Long-term safety: Incidence of adverse events

  approximately 3 years

Secondary Outcomes (2)

• Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR)

  approximately 3 years

• Proportion of patients achieving inactive disease/clinical remission

  approximately 3 years

Study Arms (1)

RoActemra/Actemra

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks

RoActemra/Actemra

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment
• Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

You may not qualify if:

• Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
• Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or current participation in another clinical trial except WA19977
• Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
• Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
• Any significant concomitant disease or medical or surgical condition
• History of significant allergic or infusion reactions to prior biologic therapy
• Currently active primary or secondary immunodeficiency
• Current abuse of alcohol, drugs or chemical abuse
• Known and currently active acute, subacute, chronic infections or history of recurrent infection; patients suffering from ongoing active infections with Epstein Barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided
• Positive for latent tuberculosis (TB)
• Currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for \>/= 2 weeks within 6 months prior to entering the study
• Inadequate hepatic, renal or bone marrow function

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 20551030, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 21941-912, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 16, 2012
• Study Start: March 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

BR (4)